Xenical orlistat regulatory update

EMA began a review of serious liver injuries reported in patients receiving medicines containing orlistat for obesity. The agency said it identified 21 suspected cases of hepatic events, of which 4 were cases of severe liver toxicity, in patients receiving orlistat during 2009-11. Roche markets 120 mg Xenical orlistat for prescription use, while GlaxoSmithKline markets 60 mg orlistat as alli as an OTC product.

Last year, FDA revised the label for orlistat to include a warning about rare reports of severe liver injury after an agency review identified 13 total cases, including 2 deaths and 3 liver transplantations, that occurred during 1999 and 2009. ...